510(k) K240052
K240052 is an FDA 510(k) premarket notification submitted by Beijing L&Z Medical Technology Development Co., Ltd. for the device "Disposable Enteral Feeding Sets". The FDA issued a decision of Substantially Equivalent on July 3, 2024. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Beijing L&Z Medical Technology Development Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2024
- Date Received
- January 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
To facilitate enteral specific connections.